Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety of sts101 in the acute treatment of migraine

Conditions: Migraine; Migraine With Aura; Migraine Without Aura

Summary: study sts101-003 is a multi-center, multiple dose (prn), open-label, 12-month study to evaluate the safety and tolerability of sts101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

the ascend trial is a multi-center, multiple dose (prn), open-label, 12-month study to evaluate the safety and tolerability of sts101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Eligibility criteria:
key inclusion criteria: * males or females, 18-65 years of age at the time of screening visit * subject has at least 1-year history of migraines (with or without aura), according to the * international classification of headache disorder, 3rd edition (ichd3) key exclusion criteria: * pregnant or breast-feeding women * women of child-bearing potential not using or not willing to use highly effective contraception. * diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache. * history of coronary artery disease, coronary artery vasospasm (including printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery. * history of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage. * diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or bipolar disorder), dementia. other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety. * any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.

Keywords: dihydroergotamine dihydroergotamine mesylate migraine
effects of robotic gloves along with task-oriented mirror therapy on motor functions of hands in sub-acute stroke patients

Conditions: Stroke; Mirror Therapy; Robotics; Neurorehabilitation

Summary: this study is randomized control trial and purpose of this study is to find effects of robotic gloves assisted task-oriented mirror therapy in comparison with task-oriented mirror therapy on motor functions of hand in sub-acute stroke patients.

motor functions of the hand involve different movements and activities that the hand can perform due to the coordination of different muscles group in everyday activities which involves dexterity, manipulative skills and task performance skills which includes grasp, release and different types of grips of hand. rationale: while the mirror therapy has been studied extensively and literature provide good quality of evidence for effects of mirror therapy on motor functions of hands the integration of pneumatic robotic mirror therapy is relatively less explored . and there is no comparison between task oriented mt and pneumatic robotic mirror therapy significance this study will increase the understanding and therapeutic potential of robotic gloves assisted task-oriented mt mirror therapy and will demonstrate its efficacy as beneficial interventions. modern devices like robotic gloves can potentially increase patient compliance by providing positive outcomes, setting goals and improving functional performance. they can make therapy more engaging, interactive and help the patients track their progress, which can motivate them to adhere to their rehabilitation program. hypothesis alternate hypothesis there will be a statistically significant difference in the effects of task oriented mirror therapy in comparison with robotic gloves assisted task-oriented mirror therapy on motor functions of hand in patients with sub-acute stroke (p\<0.05). null hypothesis there will be no statistically significant difference in the effects of task oriented mirror therapy in comparison with robotic gloves assisted task-oriented mirror therapy on motor functions of hand in patients with sub-acute stroke (p\>0.05).

Eligibility criteria:
inclusion criteria: * 40 years and above. * ischemic (mca) stroke. * male and females both. * montreal cognitive assessment (moca score \>24 points). * motor power of proximal upper extremity at least 3 with ability to reach out. * fma score for upper extremity below 47 * modified ashworth spasticity score \<2 in hands and finger joints. * ability to sit for at least 60 minutes exclusion criteria: * musculoskeletal problems such as severe pain in any joints of the paretic upper extremity. * contractures in shoulder, elbow, hand or finger joints. * severe visual impairments.

Keywords: stroke mirror therapy robotics neurorehabilitation
evaluation of systemic microvascular reactivity in patients with resistant hypertension

Conditions: Arterial Hypertension; Resistant Hypertension; Microvascular Rarefaction; Endothelial Dysfunction

Summary: systemic arterial hypertension is a serious health problem worldwide. in some cases, it can phenotypically present as resistant arterial hypertension, which consists of blood pressure levels outside the treatment goals in patients using three or more classes of antihypertensive drugs, one of which is preferably a thiazide diuretic. resistant hypertension contributes to a 47% higher risk of developing cardiovascular events when compared to patients with non-resistant hypertension. it is known that the microcirculation plays a relevant role in the pathophysiology of arterial hypertension. furthermore, it is known that the cutaneous microvascular network is an adequate model and that it reflects the systemic microcirculation. in this sense, the present research proposes the study of cutaneous capillary density - through high resolution intravital microscopy - and of the endothelium-dependent and independent microvascular vasodilator response - by the speckle laser flowmetry method coupled to a pharmacological system of micro- iontophoresis - in patients diagnosed with resistant hypertension, with the aim of identifying changes in comparison with patients with non-resistant hypertension and normotensive individuals. additionally, the evaluation of the association between systemic microvascular function and the presence of target organ lesions in this population may indicate that this is a new non-invasive way of stratifying cardiovascular risk in these individuals.


Eligibility criteria:
inclusion criteria: * resistant hypertension exclusion criteria: * pregnancy or lactation for all groups. * for the control group: endocrine and metabolic diseases, including diabetes mellitus, cardiovascular diseases, including hypertension, autoimmune diseases and cancer. * for the resistant arterial hypertension and non-resistant arterial hypertension groups: endocrine diseases, except diabetes mellitus, autoimmune diseases and cancer .
safety and effectiveness of minimally invasive micro sclerostomy (mims®) to reduce intraocular pressure in open-angle glaucoma which is not controlled despite polypharmacy

Conditions: Primary Open Angle Glaucoma; Open Angle Glaucoma

Summary: the goal of this clinical trial is to show non-inferiority of the mims® device/procedure with mitomycin-c, in terms of its surgical success rate, compared to trabeculectomy with mitomycin-c in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy. eligible screened participants will undergo the mims® procedure and will be followed for a period of 12 months in this single-arm study. investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with mitomycin-c.


Eligibility criteria:
inclusion criteria: 1. male or female, ≥ 40 years to ≤ 85 years old 2. inadequately controlled primary open angle glaucoma with screening mean diurnal iop of ≥ 21 mmhg and ≤ 40 mmhg despite polypharmacy 3. primary open angle glaucoma diagnosis based on: 1. visual field mean deviation of -3db or worse and 2. glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos 4. presence of healthy, free, and mobile conjunctiva in the target quadrant 5. prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., istent, trabectome, gonioscopy-assisted transluminal trabeculectomy \[gatt\]) 6. subject is able and willing to attend all scheduled follow-up exams 7. subject understands and signs the informed consent

Keywords: open angle glaucoma polypharmacy intraocular pressure mims minimally invasive glaucoma surgery migs mtmt
hemostasis in patients with idiopathic thrombocytopenic purpura

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: the investigators are trying to investigate the coagulation status of idiopathic (immune) thrombocytopenic purpura patients by measuring the platelet count, coagulation battery, von willebrand factor level, thromboelastography.

in patients with chronic coagulation disorder, laboratory model and clinical data have shown evidence for a rebalanced hemostasis. previous study showed that the platelet count may not predict the risk of bleeding since the platelet count is not an indicator of platelet function. thromboelastography may be the choice of investigation when platelet function is in question especially in patients with idiopathic (immune) thrombocytopenic purpura (itp). previous study have shown that maximum clot formation is the most important thromboelastography parameter in predicting bleeding in itp patients that makes thromboelastography superior to other hemostatic tests. the investigators are trying to evaluate the rebalanced hemostasis in patients with itp by comparing the value of platelet count, von willebrand factor antigen level, and thromboelastography parameters.

Eligibility criteria:
inclusion criteria: * those who visits the outpatients clinic of samsung medical center with a diagnosis of idiopathic (immune) thrombocytopenic purpura (itp)between march, 2012 and february, 2013. * those with age between 20 and 70 yrs old exclusion criteria: * those with other causes of thrombocytopenia other than itp

Keywords: rebalanced hemostasis idiopathic thrombocytopenic purpura coagulation status
microecology and immunity in patients with anti-mda5 antibody positive dermatomyositis and interstitial lung disease

Conditions: Microbiome; Immune Function; Anti-MDA5 Antibody Positive Dermatomyositis

Summary: the purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-mda5 antibody positive dermatomyositis.

methods: bronchoalveolar lavage specimens of patients with anti-mda5 antibody positive dermatomyositis and interstitial lung disease were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Eligibility criteria:
inclusion criteria: * patients who meet the diagnostic criteria of dermatomyositis and anti-mda 5 antibody positive. * anti-mda5 antibody positive dm patients with rpild meet the diagnostic criteria for rpild. * must have undergone bronchoalveolar lavage. * age≥18 years old. * patients who signed informed consent forms exclusion criteria: * patients who had other connective tissue diseases. * patients with ild or rpild caused by infection, tumors, drugs, biochemistry and other factors. * pregnant or lactating patients. * the patient also participated in any other clinical trial. * disagreement for inclusion in this study
cross-sectional study to define and validate "doctor/pharmacy shopping" as outcomes suggestive of abuse and/or addiction

Conditions: Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Summary: the purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction

based on a review of the literature, the food and drug administration (fda) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (er/la) opioid analgesics. thus, the fda is requiring that er/la opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. the four observational post-marketing requirement (pmr) studies are labeled study #2065-1, study #2065-2, study #2065-3, and study #2065-4. the objective of pmr study #2065-4 is to define and validate "doctor/pharmacy shopping" as outcomes suggestive of misuse, abuse and/or addiction. study #2065-4 consists of three sub-studies, study 4a, study 4b, and study 4c. in the current study (#2065 sub-study, study 4a), the ims® lrx database, a longitudinal pharmacy database that captures both third-party and self-pay transactions, will be linked to the pharmetrics plus™ database, which contains provider, facility and pharmacy claims. from these databases, patients with shopping behavior will be identified and evaluated against an algorithm for abuse/addiction that will be developed and validated in pmr study #2065-3b. study #2065-3b will review the literature for health information suggestive of abuse/addiction in medical charts and medical claims. then, through iterative processes that involve experts reviewing claims profiles and medical charts, text searches of medical records using natural language processing and supervised machine learning will identify and create a compilation of codes and health information with the best specificity and sensitivity to identify patients with opioid abuse/addiction. the compilation of codes and health information will be used to develop the algorithm that study 4a will apply to define abuse/addiction. restricting the validation of shopping behavior to only patients with diagnoses related to abuse would ignore the population with undiagnosed abuse. by supplementing icd-9 codes with other information available on claims (e.g., addiction treatments, emergency visits) to define abuse/addiction, the measurement bias will be decreased and the estimates of the association of shopping behavior with abuse/addiction will be more valid. categories of doctor shopping will be derived from the population distributions of the multiple variables analyzed for opioid users. the 4 categories will range from no shopping behavior (lowest level) to extensive shopping behavior (most extreme). the specifics of how the categories will be defined will be driven by the data.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. minimum of two dispensings for ir or er/la opioids or two or more diuretic dispensings exclusion criteria: n/a
a gene transfer study for late-onset pompe disease (resolute)

Conditions: Pompe Disease; Pompe Disease (Late-onset); Glycogen Storage Disease Type 2; Glycogen Storage Disease Type II; LOPD; Lysosomal Storage Diseases; Acid Maltase Deficiency

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of spk-3006 in adults with clinically moderate, late-onset pompe disease receiving enzyme replacement therapy (ert). participants will be treated in sequential, dose-level cohorts.


Eligibility criteria:
inclusion criteria: * provide written informed consent; * males and females ≥18 years of age with late-onset pompe disease; * received ert for at least the previous 24 months * have clinically moderate, late-onset pompe disease characteristics; * agree to use reliable contraception. exclusion criteria: * active hepatitis b and/or c; * significant underlying liver disease; * human immunodeficiency virus (hiv) infection; * prior hypersensitivity to rhgaa; * pre-existing anti-aav neutralizing antibody titers; * high titer antibody responses to rhgaa; * requires any invasive ventilation or requires noninvasive ventilation while awake and upright; * received any prior vector or gene transfer agent; * active malignancy (except non-melanoma skin cancer); * history of liver cancer; * pregnant or nursing women; * any evidence of active infection at the time of spk-3006 infusion.
ultrasound quadratus lumborum block vs fascia iliaca block in pediatrics undergoing hip surgery .

Conditions: Developmental Dysplasia of the Hip

Summary: comparison between ultrasound guided transmuscular ql block and fascia iliaca block in pediatric patients undergoing ddh surgery regarding the quality of pain control in the perioperative period..


Eligibility criteria:
inclusion criteria: * children aged 2-12 years * of both sexes * american society of anesthesiologist (asa) physical status classification class i * undergoing general anaesthesia for ddh surgery exclusion criteria: * parents' refusal of regional block * duration of surgery over 120 min. * history of allergy to local anesthetics * bleeding disorders (inr \>1.4, platelet count\< 75000)

Keywords: ultrasound quadratus lumborum fascia iliaca
preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance

Conditions: Acute Phase Response; Insulin Resistance

Summary: prolonged fasting may increase the organic response to trauma. carbohydrate-based drinks have been tested and they may reduce insulin resistance. no study so far has aimed to examine the possible benefits of whey protein drink in the composition of preoperative drinks.

the patients will be randomized into two groups: the carbohydrate-protein group (cho-p) and the control group (co). the patients will reeive a specific drink to their group on the evening prior to surgery and three hours before the operation. the cho-p group will receive 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (resource® breeze - nestlé, são paulo, brasil) and the co group will receive the same volume of water. outcome measures on the day of the surgery and on the first postoperative day blood samples will be collected for glucose, insulin, triglycerides, albumin, pre-albumin, crp, and α-1-acid glycoprotein (α-1-ga) assays. homa-ir will be calculated

Eligibility criteria:
inclusion criteria: * adults (18-65 years-old) * both sexes * candidates to elective moderate operations such as open cholecystectomy, laparoscopic cholecystectomy and unilateral repair of inguinal hernia). exclusion criteria: * acute cholecystitis * diabetes mellitus * chronic kidney failure * chronic liver disease ot serum bilirubin greater than 2 mg/dl, body mass index (bmi) above 35kg/m2 * american anesthesiologists association (asa) score above 2 * gastro-esophageal reflux * gastroparesis or intestinal obstruction * patients with any non-compliance with the study protocol, or who had associated operations, or presented significant intraoperative occurrences, or experienced prolonged operations (lasting more than 3 hours) were also excluded.

Keywords: preoperative fasting insulin resistance carbohydrates whey protein inflammatory response
multifocal-toric iol compared to multifocal iol combined with limbal relaxing incisions for correction of moderate astigmatism during cataract surgery

Conditions: Cornea; Astigmatism; Cataract

Summary: the purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.

this is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 d (doctrine) took part in the trial. the trial assessed the efficacy of multifocal iol (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric iol or a standard multifocal iol combined with limbal relaxing incisions.

Eligibility criteria:
inclusion criteria: * bilateral cataract and be planning to have both eyes operated on. * age 21 and older * have cataracts that allow iol master biometry * regular corneal astigmatism 1.00 up to 2.50 d * difference of corneal astigmatism in both eyes to be equal to or less than 0.75d * written informed consent to surgery and participation in the study * speak english exclusion criteria: * relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. marfan syndrome) * irregular corneal astigmatism on pentacam topography

Keywords: multifocal iol astigmatism incision cataract surgery implant
a survey of hospitalizations in cardiology units in sub-saharan africa

Conditions: Acute Coronary Syndrome; Heart Failure; Syncope; Stroke; Pericarditis; Endocarditis; Conduction Abnormalities; Rhythm; Abnormal; Pulmonary Embolism; Deep Vein Thrombosis; Other Cardiovascular Conditions

Summary: fevrier study is an observatory of hospitalizations in cardiology units in sub-saharan africa.

fevrier is an observational study based on a questionnaire completed by investigators for each hospitalization in cardiology unit during the month of february.the investigator is a physician of the participating hospital. fevrier evaluates the modalities of care management. it will take place in cardiology units of hospitals of sub-saharian countries one month per year (month of february) during 5 years. the investigator will thoroughly complete: * one information form describing the hospital and the department * one questionnaire (2o questions) for each hospitalized patient patients with at least one day of hospitalization will be enrolled in the study. on the first day of february, all patients already hospitalized will be enrolled and all patients hospitalized in the last day of february will be followed until their discharge. thus, data collection will start 1st day of investigation, during february and will continue until the discharge of the last enrolled patient.

Eligibility criteria:
inclusion criteria: * to be hospitalized in a cardiology department of a participating center during the month of february exclusion criteria: * refusal

Keywords: routine care, evaluation, africa, observatory